| Ethics applications |
Application submission |
Ethics
applications
Most research involving
humans will require ethical review, and the level of review will be
commensurate with the level of risk to which participants are exposed.
Research that
can be exempted from review
If the
research has negligible risk
and involves the use of totally
non-identifiable data
about humans, ethical review may not be necessary.
If you think your
research is exempt from ethical review, please
submit an ‘application-by-letter’
addressed to the Ethics Manager,
The Alfred Hospital, and email it to
research@alfred.org.au. The letter should provide all details to justify
a waiver of the requirement for ethical review.
Research that has negligible risk but does use data that could
possibly identify individuals is not exempt from ethical review.
Low risk research
If the research cannot be
exempt from review, is
negligible or
low risk, full ethical review may not be required. If you think your
research fits into this category, please read the
Low Risk Guide and if appropriate complete the
application for ethical review of low risk projects (MS Word)
and submit it to
research@alfred.org.au for opinion.
When you
have completed your low risk project, please submit the
Low Risk Final Report.
More than low risk research
For all research more than low risk, full ethical review is required and you
will be required to complete and submit a full application to the Ethics
Committee for review and approval.
There are three methods
of applying for ethics approval. Researchers are advised to read each option
carefully and make a choice depending on the type and scope of the study.
Please choose one
of the following:
National Ethics Application Form
(NEAF) National (accepted Australia-wide)
Victorian 'Common Application Form' (CAF)
(accepted at Alfred Health and some other Victoria centres)
National Ethics Application Form
(NEAF) Streamlined (for Victorian multi-centre clinical
trials)
Please also familiarise yourself with the
Alfred Ethics Committee guidelines page, covering a range of research
activities.
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Submitting your application to the
Ethics Committee
This applies to all types of applications
requiring full ethical review.
Step 1 -
Project registration
To register
an application, download the appropriate application forms and complete
them. You will then need to submit the application by email to
research@alfred.org.au
by the
project registration date.
Electronic signatures are not necessary at this stage, but original hard
copy signatures must be submitted with the project submission.
NEAF applications done on-line need to be
saved as a PDF and emailed to us as a document attached to the email, rather
than using the on-line email notification process.
Resource centre
declarations and radiation safety documentation may be incomplete at the
time of project registration. These and any additional documentation that
cannot be emailed are to be included in the full, hard copy submission.
Please indicate in your
project registration email which documentation is missing.
For immediate confirmation that your email has reached us, set up an automated 'Delivery Receipt Notification'
before you send your email.
Step 2 - Project
submission
At registration time, the
application will be checked for completeness by the Ethics Office and any
omissions or changes requested will be conveyed to you by email. You will
receive detailed submission instructions from us, such as a unique project
number, the number of paper copies required and the date for full project
submission.
You will also be asked to submit an
electronic version of the complete application at full project submission
time, incorporating any requested changes.
All hard copy documentation is to be collated
as instructed before project submission so that each item of supporting
documentation is attached to each copy of the application. Individual items
such as indemnity statements, CVs, CTN forms and clinical trial research
agreements (CTRAs) are to be placed with the original, paper application.
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